VOMP3001: A Doctor Is About To Inject An Aseptically Manufactured Injectable Finished Pharmaceutical
Scenario: A doctor is about to inject an aseptically manufactured injectable finished pharmaceutical into the arm of a child.
How would you convince both the patient’s parents and the doctor that the manufacturing process was robust and to proceed in confidence with the administration?
What are the biggest risks to the child?
How are they controlled?
Question 2:
Examine the graphical representation on the next page for “A Validation Approach for a Complex Project, Consisting of Many Systems and Components”.
In terms of “Qualification Rationale”, describe the process of a system-impact-assessment and component-level-impact assessment.
In your own words define the term installation qualification (IQ).
In your own words define the term operational qualification (OQ).
In your own words define the term performance qualification (IQ).
Briefly describe the inter-relationships between the following operational activities for a computerized system in a GxP environment.
Handover
Establishing and Managing Support Services
Performance Monitoring
Incident Management
Corrective and Preventive Action
Operational Change and Configuration Management
Repair Activity
Periodic Review
Backup and Restore
Business Continuity Management
Security Management
System Administration
Archiving and Retrieval
Question 4:
Examine the diagram on the next page for a typical vertical processing facility designed for batch API production.
Describe, with reference to the diagram, how synthetic API plants (Batch Organic Chemical Synthesis) normally follow a sequence to produce a solid product:
Reaction (Continuously Stirred Tank Reactor (CSTR))
Crystallization
Separation
Drying
Question 5:
Study the following diagram that represents the basic unit operations that most companies implement when manufacturing a biopharmaceutical protein-based drug substance.
Briefly describe the following three stages of a typical process:
Stage I: Upstream Processing
Stage II: Fermentation
Stage III: Downstream Processing
Question 6:
Describe the principals for a typical cleaning validation sequence as listed below:
Use the equipment for the process
After processing hold the equipment and allow to dry
Clean as per the procedure
Sample for product residue, cleaning-agent residues, and others
Repeat twice more, giving three (3) consecutive runs
Develop on post-cleaning monitoring strategies
Question 7:
Describe the primary process principals of a typical pharmaceutical tableting operation. List three (3) critical parameters that must be controlled.
Question 8:
Combining the principals of the FDA’s approach to medical device classifications with the EU Medical Device Directive 93/42/EEC, list three devices in the following categories giving reasons for your answers: